[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44405-44406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17181]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-875]


Importer of Controlled Substances Application: Globyz Pharma, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Globyz Pharma, LLC. has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplementary Information listed below for further drug information.

[[Page 44406]]


DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before September 13, 
2021. Such persons may also file a written request for a hearing on the 
application on or before September 13, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on May 7, 2021, Globyz Pharma, LLC., 2101 Market Street, 
Suite 5, Upper Chichester, Pennsylvania 19061-4001, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Lisdexamfetamine.......................     1205  I
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    The company plans to import finished dosage unit products of 
Lisdexamfetamine for the one time need of analytical testing. No other 
activity for this drug codes is authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17181 Filed 8-11-21; 8:45 am]
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